Category Archive

As a CMO, Singota has chosen a cross-functional staffing model, spanning the functions of sampling/dispensing, formulation, filling, and finishing. Cross-functional staffing entails cross-training so that each employee can make the most of the skills they bring to the company, while acquiring new skills and perspectives.

This series of blog posts on CMO risk mitigation has been focused on the challenge of building an effective working relationship with the contractor a pharmaceutical company chooses to manufacture a drug. This third and final post in this series addresses the problem of bridging the gap from the laboratory to the manufacturing floor.

In the second of this series of three blog posts, the next objective is to identify Critical Process Parameters (CPPs) – the key variables in a production process that affect Critical Quality Attributes.

In sterile product manufacture, CPPs fall into two main categories: Formulation and Fill/Finish

This post is the first in a series of three on the subject of CMO risk mitigation. Our focus will be to establish methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.
In these posts we will try to help managers evaluating contract manufacturing to:
-Determine how to work with the CMO to determine critical process parameters;
-Explore strategies to control or eliminate process variables; and
-Learn how to bridge the gap from lab scale to manufacturing scale

Among the key sources of delay in the development process is the length of the clinical trial process. In recent years, the FDA has allowed some pharmaceutical companies to mitigate these risks, and costs, by approving testing through what are called “Adaptive Clinical Trials.”